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Open Label Trial of Armodafinil Shows Promise in DLB

June 12, 2012 - At the American Academy of Neurology’s annual meeting in April, researchers from the Mayo Clinic reported on a small clinical trial which assessed the safety, tolerability and efficacy of armodafinil therapy for excessive sleepiness (hypersomnia) associated with dementia with Lewy bodies (DLB).

Twenty subjects were enrolled in this open label trial, with three individuals who did not complete the trial due to worsening disease or death from community-acquired pneumonia. Individuals in the study had mild to moderate dementia and were already being treated with medications routine in DLB clinical care for dementia, behavior, sleep and movement symptoms. Individuals were treated for 30 days with 150 mg armodafinil to establish safety and tolerability and were increased to 250 mg for an additional 60 days.

Mild to marked clinical improvement was observed in 90% of participants, with moderate to marked improvement seen in 45% of participants. Improved caregiver quality of life was reported as well. “The majority of patients experienced some degree of improvement in key features associated with DLB, and most tolerated the medication without significant side-effects,” said Dr. Brad Boeve who directed the trial. “Yet some patients continued to experience significant daytime sleepiness and other problematic DLB features. This medication should obviously not be considered a cure for DLB, but it is another option for clinicians and patients to consider as they work together in treating bothersome symptoms associated with DLB – particularly excessive daytime sleepiness.” Significant improvement over baseline was reported in the ability to maintain wakefulness, and significant improvement was reported in apathy and improvement occurred in visual hallucinations, delusions and anxiety, with the exception of the 3 individuals who discontinued participation.

This data suggests treatment with armodafinil offers reasonable safety, tolerability and improvements over baseline in excessive sleepiness in individuals with DLB, and may reduce neuropsychiatric features as well.